GI CANCERS

The FDA’s Oncologic Drug Advisory Committee voted 13 to 4 for the deferral of the FDA approval of retifanlimab for the treatment of patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy, pending more research.

Relacorilant administered in combination with nab-paclitaxel elicited responses in patients with metastatic pancreatic cancer, leading to the halting of enrollment in the phase 2 RELIANT trial.

Sintilimab injection in combination with chemotherapy showed a statistically significant and clinically meaningful improvement in overall survival as frontline treatment of patients with unresectable, locally advanced recurrent or metastatic esophageal squamous cell carcinoma.

The FDA has granted an orphan drug designation to gunagratinib (ICP-192) for the treatment of cholangiocarcinoma.

An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.

Pimitespib, a heat shock protein 90 inhibitor doubled the progression-free survival and prolonged the overall survival compared with placebo in patients with advanced gastrointestinal stromal tumor that is refractory to imatinib, sunitinib, and regorafenib, according to results from the phase 3 CHAPTER-GIST-301 trial.

The combination of regorafenib and avelumab showed modest anti-tumor activity and survival rates in patients with heavily-pretreated biliary tract solid tumors.

Data from the phase 2 NIFTY trial demonstrated that a combination with liposomal irinotecan significantly improved survival in patients with metastatic biliary tract cancer.

Patients with advanced gastrointestinal stromal tumor after receiving fourth-line therapy had extended progression-free survival when given an intra-patient dose escalation of ripretinib to 150 mg twice a day following progression.

The FDA has granted accelerated approval to the oral FGFR1-3 selective inhibitor, infigratinib for the treatment of patients with cholangiocarcinoma who harbor an FGFR2 gene fusion or rearrangement.

Treatment options are available for patients with late-stage gastric cancer in the early- to late-line settings.

The FDA granted approval to adjuvant nivolumab as treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy.

Research characterizing the relationship between this heterogeneity and response to targeted therapies can lead to improved selection of patients who will benefit from specific therapies.

The latest updates on gastric and esophageal cancers focus on greater use of biomarkers, next-generation sequencing (NGS), and immunotherapies.

Jaffer A. Ajani, MD led a discussion around biomarkers to consider when determining systemic therapy for patients with stage IV gastric adenocarcinoma.

The FDA has granted orphan drug designation to the first-in-class ruthenium-based small molecule, BOLD-100, for the treatment of patients with gastric cancer.

The FDA has granted accelerated approval to pembrolizumab plus trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the frontline treatment of patients with locally advanced unresectable or metastatic HER2 positive gastric or gastroesophageal junction cancer.

The FDA accepted a supplemental new drug application for ivosidenib tablets and granted it priority review for the treatment of patients with previously treated IDH1-mutated cholangiocarcinoma.

A rolling submission of a new drug application to the FDA has been initiated for surufatinib as a potential treatment option for patients with pancreatic and extra-pancreatic neuroendocrine tumors.

In an interview with Targeted Oncology, Mark E. Johns, MD, discussed landmark esophageal cancer studies, newly approved treatments, and the future of the space.

Although chemotherapy is the mainstay of systemic treatment for advanced cholangiocarcinoma, there are limited treatment options when the disease progresses

The FDA has granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2b overexpression or amplification.

The FDA has lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.

The FDA has approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

The FDA has approved a higher dose of cetuximab for the treatmen of patients with KRAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck.